Method and apparatus for coating a medical device

• US 7,709,048 B2
• Filed: 11/05/2004
• Issued: 05/04/2010
• Est. Priority Date: 05/02/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Labcoat Ltd. (Boston Scientific Corporation)
• Inventors: Teichman, Eyal, Schrift, Avner
• Primary Examiner(s): Meeks; Timothy H
• Assistant Examiner(s): Sellman; Cachet I
• Application Number:
  US10/982,408
• Publication Number:
  US 20060073265A1
• Time in Patent Office: 2,006 Days
• Field of Search: 427/2.1, 427/2.24, 118668-669, 118/676, 118679-680
• US Class Current: 427/2.24
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/30322 differing in surface structures
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: B05B 12/122 responsive to presence or shape of target B05B12/124 takes precedence
• CPC Class Codes: B05B 13/0442 Installation or apparatus for applying liquid or other fluent material to separate articles rotated during spraying operation
• CPC Class Codes: B05C 5/0216 by relative movement of article and outlet according to a predetermined path

Abstract

A method and device, for use in an operating theater just prior to implantation, for selectively applying a medical coating to an implantable medical device. Disclosed is a device for use with a stent deployed on a catheter balloon configured to apply a medical coating of a desired thickness to the surface of the stent only. A drop-on-demand inkjet printing system in association with an optical scanning device is described. The device is further configured to apply a plurality of layered coats, each layered coat being of a different coating material, and if appropriate, different thickness and to coat a portion of the medical device as a function of its geometric configuration. The coating is applied by moving an applicator over the device in a path that is independent of the deposited coating pattern.

Claims

1. A method of coating a medical device, the method comprising:

optically scanning the medical device and obtaining a plurality of views of the medical device;

merging the plurality of views to generate a digital representation of the medical device;

processing the generated representation to generate a topology of the medical device;

determining a first plurality of reference locations on the generated topology wherein each location of the first plurality of locations corresponds to a location on the medical device at which at least one drop of coating material is to be placed;

generating a second plurality of locations as a function of the first plurality of reference locations, wherein each location of the second plurality of locations defines a physical point on the medical device; and

depositing at least one drop of coating material on at least one location in the second plurality of locations with an applicator, wherein the movement of the applicator relative to the medical device does not substantially follow the topology of the medical device.

2. The method as recited in claim 1, further comprising:

rotating the medical device on its longitudinal axis such that each view of the plurality of views is of a different angular portion of the medical device.

3. The method as recited in claim 1, wherein the medical device is a stent comprising a plurality of struts and processing the generated representation to generate the topology comprises:

detecting at least one of;

an edge of a strut; and

a mid-line of a strut,

wherein the first plurality of locations are determined to lie along at least one of;

the edge of a strut and the mid-line of a strut.

4. The method as recited in claim 1, further comprising:

representing each location of the first plurality of locations as a function of pixels in a device used to scan the medical device; and

converting each location of the first plurality of locations to a corresponding second plurality of physical locations on the medical device,

wherein each location in the second plurality of locations comprises a linear component and an angular component.

5. The method as recited in claim 4, further comprising:

ordering the second plurality of locations in a sequence to place the coating material drops on the medical device in a helical pattern when a coating applicator is moved in a helical path over the medical device.

6. The method as recited in claim 1, further comprising:

merging the plurality of views to obtain a three-dimensional representation of the medical device.

7. The method as recited in claim 1, wherein each view of the plurality of views is from a different angular position about the circumference of the medical device.

8. The method as recited in claim 1, wherein the medical device is a stent comprising a plurality of struts, each strut having an exterior surface, interior surface and side surfaces therebetween, and wherein:

generating the topology comprises detecting at least one edge of a strut,

determining the first plurality of locations as being along the detected at least one edge of the strut; and

selecting coating material characteristics such that coating material placed along the at least one edge of the strut flows to coat the side surfaces.

9. A method of loading a stent with a medicinal compound, the stent comprising a plurality of struts, the struts being in a geometric pattern, the method comprising:

scanning the stent to identify one or more edges of the struts;

determining a first set of coordinates for the indentified one or more edges of the struts;

generating a second set of coordinates as a function of the first set of coordinates; and

ejecting the medicinal compound at each coordinate in the second set of coordinates with an applicator, wherein the movement of the applicator relative to the stent does not substantially follow the geometric pattern of the struts.

10. The method of claim 9, wherein scanning the stent comprises:

optically scanning the stent; and

detecting an optical difference between a strut and anything not a strut.

11. The method of claim 10, wherein scanning further comprises:

capturing an image of the stent struts.

12. The method of claim 10, wherein generating the second set of coordinates comprises:

identifying coordinates for a surface of a strut form the first set of coordinates; and

generating the second set of coordinates as coordinates shifted from the first set of coordinates and away from the identified strut surface coordinates.

13. The method of claim 12, wherein ejecting the medicinal compound comprises:

ejecting the medicinal compound from an ink jet applicator.

14. The method of claim 10, wherein the optical difference is determined as a function of light reflecting off of the stent.

15. A method of loading a medicinal compound on a stent comprising a plurality of struts, the struts being in a geometric pattern, the method comprising:

illuminating the stent with light from a light source;

capturing an image of the illuminated stent;

processing the captured image and generating a first set of coordinates corresponding to edges of the stent struts;

processing the first set of coordinates to generate at least one bounded area coordinate in an area bounded by edges of the stent struts; and

directing at least one drop of the medicinal compound toward the at least one bounded area coordinate;

applying the drop with an applicator, wherein the movement of the applicator relative to the stent does not substantially follow the geometric pattern of the struts.

16. The method of claim 15, wherein capturing an image comprises:

storing the captured image as digital information; and

processing the captured image comprises differentiating the stored digital information representing the stent struts from the stored digital information that represents a part of the captured image that is not a stent strut.

17. The method of claim 16, wherein capturing an image of the illuminated stent comprises:

optically scanning the stent.

18. The method of claim 15, wherein directing at least one drop of the medicinal compound comprises:

ejecting the at least one drop from an ink jet device.

19. The method of claim 18, further comprising:

positioning the ink jet device substantially at the at least one bounded area coordinate prior to ejecting the at least one drop.